AUA Submits Statement
on Saw Palmetto

In
response to a request from the Food and Drug Administration (FDA), the
AUA prepared a written statement specifying its position on food supplements
containing saw palmetto. The FDA is currently fighting a lawsuit filed
by makers of the saw palmetto supplement.

The American Urological Association (AUA) representing 9,500 urologists
in the United States appreciates the opportunity to present its views
on the issues of food supplements containing saw palmetto. The AUA wishes
to emphasize, once again, in the strongest possible terms that lower urinary
tract symptoms in older men (urinary frequency, urinary urgency, slowing
of the urinary stream, hesitation on initiation of urination and rising
at night to void multiple times) are often due to diseases of the genitourinary
system. They are usually NOT a normal phenomenon of aging. The AUA is
deeply concerned that food supplements containing saw palmetto currently
being offered to maintain prostate health, to treat benign prostatic hyperplasia
(BPH) or to alleviate lower urinary tract symptoms could be very misleading
to the public. Life-threatening cancers (cancer of the prostate and cancer
of the urinary bladder) can cause lower urinary tract symptoms. The AUA
is concerned that men experiencing such symptoms may self-medicate with
food supplements containing saw palmetto, thus, delaying the timely and
proper diagnosis of their cancers. The AUA is concerned that the package
inserts accompanying these supplements, no matter what admonitions they
might contain, are infrequently read by the user or, if read, are ignored
or misunderstood.

The
AUA is also concerned about the safety of food supplements containing
saw palmetto for lower urinary tract symptoms. Most products currently
being marketed in the United States for lower urinary tract symptoms and
BPH are combinations of multiple ingredients. Each product is often different
from the other. The various multiple components could differ within each
individual product.

The AUA very strongly believes that each of these products marketed for
lower urinary tract symptoms and BPH should be individually tested for
safety given that each product could be different. Further, the AUA believes
that each product should be tested for possible drug interactions with
the wide variety of prescription medications (anti-hypertensives, anti-diabetics,
mood-altering drugs, cardiac medications and other pharmacological agents),
which are so commonly being taken by older men. Such testing and study
could insure that a specific saw palmetto containing food supplement product
poses no serious threat of adverse drug reactions when taken with other
pharmacological agents. The AUA believes that there currently exists inadequate
medical data ruling out possible serious interactions.

In
a randomized, placebo-controlled, six-month study of 44 men with lower
urinary tract symptoms and an enlarged prostate gland upon digital rectal
examination, Marks and coworkers [1] reported no adverse events in his
cohort of patients taking the herbal product containing saw palmetto,
which was under study. However, an entry criteria into the study was that
the men "be in good general and mental health." No data were given about
the prescription medications those men on the herbal compound containing
saw palmetto might have been taking at the time of the study. Thus, no
data regarding prescription drug interaction can be gleaned from this
small study since the men in this study were in good health and might
not have been taking any such prescription medications.

Our Association believes it is inappropriate to cite the safety data
on pure saw palmetto products currently marketed in Europe (such as Permixon
not currently available in the United States) as proof of the safety of
the mixed products containing saw palmetto being marketed in the United
States. Permixon and the United States mixed products containing saw palmetto
are not comparable, thus, making safety extrapolations scientifically
invalid.

The mission of the American Urological Association through its members
is to provide the highest quality of care to patients with genitourinary
disease. In pursuit of this mission, the AUA continually maintains an
open mind. However, the American Urological Association strongly believes
that food supplements containing saw palmetto marketed for the alleviation
of lower urinary tract symptoms, the treatment of BPH, and for the maintenance
of prostate health should be controlled by the Food and Drug Administration
(FDA) and held to the same standard as are all other pharmacological agents
intended to treat disease.

Dried Saw palmetto berries

The AUA believes that these food supplements
containing saw palmetto should be carefully studied through properly
controlled, perspective, randomized clinical trials under the auspices
of the FDA as are all other pharmacological agents being marketed
for disease control. Through such studies, the safety of food supplements
containing saw palmetto can be assessed along with any possible drug
interactions they might create.

Should proper studies confirm the safety and efficacy of food supplements
containing saw palmetto, the AUA would welcome their addition to the armamentarium
of American physicians treating men with lower urinary tract symptoms
due to benign disease.

The American Urological Association strongly urges the Food and Drug
Administration to control food supplements containing saw palmetto marketed
to alleviate lower urinary tract symptoms, to treat benign prostatic hyperplasia
or to maintain prostatic health. Proper clinical trials can resolve safety
and efficacy issues. It is our understanding that the National Institutes
of Health is actively considering setting in place clinical trials on
saw palmetto and food supplement products in the treatment of lower urinary
tract symptoms and benign prostatic hyperplasia. The American Urological
Association applauds the concept of such studies and anxiously awaits
their outcome.